1. Field of the Invention
The present invention generally relates to medical devices, and more specifically relates to packages for storing medical devices.
2. Description of the Related Art
Surgical mesh is often used during surgical procedures for supporting tissue, such as supporting tissue during a hernia repair procedure. It has been observed that using surgical mesh to repair a hernia will promote more rapid healing and minimize the likelihood of hernia re-occurrence.
A surgical mesh is typically made from a biocompatible material such as polypropylene. The mesh may be covered with one or more absorbable layers for reducing the formation of adhesions. In many instances, surgical mesh products require proper packaging that enables the mesh to remain flat so that, when deployed, the mesh does not have any creases or folds. It is also critical that the packaging maintains the surgical mesh in a sterile condition, and that the packaging enables the mesh to be easily removed from the package and presented to surgical personnel in a simple and efficient manner.
Conventional surgical mesh packages typically position the mesh within some type of sealed container or pouch with the mesh being situated between a bottom package element and a top package element that are sealed together. To open the package, surgical personnel must physically separate the top element from the bottom element, usually requiring the separation of two, three, or even four edges. Thus, the steps involved to access the surgical mesh at the time it is needed are cumbersome and time consuming.
Some attempts have been made to reduce the size of surgical mesh packages by folding the mesh prior to placing it in a package. Folding the mesh, however, tends to form creases in the mesh, which may result in the mesh irritating the surrounding tissue.
Commonly assigned U.S. Pat. No. 5,249,682 to Transue, the disclosure of which is hereby incorporated by reference herein, teaches a package for holding a medical device such as a surgical mesh. In one embodiment, the medical device includes a surgical mesh having a mesh plug attached perpendicularly thereto. The mesh is substantially flat and lies in a plane which is substantially horizontal with respect to the plug. The package includes a folder that has a central floor panel for receiving the mesh and the mesh plug assembly. A first end panel is foldably connected to one side of the central panel for retaining the mesh on the central panel. At least one reinforcing panel is foldably connected to the first end panel for providing structural strength to the package. A connecting panel foldably connected to the opposite side of the central panel is, in turn, foldably connected to an optional plug retaining panel. The optional plug retaining panel is, in turn, foldably connected to a second end panel. The reinforcing panel is folded outwardly and locked to the first end panel with locking slots and tabs, the first end panel is locked to the central floor panel with locking slots and tabs, and the second end panel is locked to the central panel with locking slots and tabs.
Commonly assigned U.S. Pat. No. 7,481,314 to Komarnycky, the disclosure of which is hereby incorporated by reference herein, teaches a package assembly for a surgical mesh including a carrier assembly having a first substantially flat, flexible protective element lying in a first plane and having a periphery, and a second substantially flat, flexible protective element having a periphery and being positioned in a second plane parallel and substantially adjacent to the first plane. The package assembly includes a substantially flat, flexible surgical mesh having first and second sides, whereby the mesh is positioned between the first and second protective elements. The first and second protective elements are further dimensioned to substantially cover the respective first and second sides of the surgical mesh. The first and second protective elements are joined together along at least a portion of their respective peripheries, but along no more of the periphery than that which will allow the first and second protective elements to be separated from one another to allow removal of the mesh by a user without separating the joined portion of their peripheries.
In spite of the above advances, there remains a need for a package for medical devices, such as surgical mesh products, that resists bending, securely holds the mesh in place, and that minimizes required storage space. There also remains a need for a package for medical devices that enables the medical device to remain flat so that, when deployed, the medical device does not have any creases or folds. In addition, there remains a need for a package for a medical device that includes a separate compartment for holding one or more accompanying instruction manuals, packages that may be assembled around the medical device, and packages that may be assembled without using any glue (e.g. a package that uses mechanical interlocking elements such as locking tabs and slits). In addition, there remains a need for a package for medical devices that avoids assembly costs associated with gluing and using double-sided tapes to complete or seal packages, and that provides rigidity with an inner chamber suitable for housing a medical device without exposing the medical device to compressive forces associated with shipping and handling. Moreover, there remains a need for a package for medical devices having a closing flap or cover that enables the package to be closed without damaging the underlying structure of the package or the contents of the package.
There also remains a need for a package for medical devices that has enhanced integrity and functionality so that surgical personnel may easily remove and control the medical device as it is removed from the package. There also remains a need for a package for dispensing medical devices that securely locks so that the medical devices do not easily spill out of the packaging when the package is opened. In addition, there is a need for medical packaging which does not require additional adhesive to secure the packaging and the medical products, thereby reducing the bio-burden and the possibility of adhesive leaching into the medical device. There also remains a need for a medical package dispenser whereby a medical device can be inserted into the package during a folding and/or tucking operation, which allows for easy filling of the package without risking folds or bends in the medical device and without risking the medical device catching a surface of the dispenser package during removal of the medical device from the package. There also remains a need for medical packaging that prevents unwanted drops or mishandling, and that allows for easy access and dispensing of the medical product. There also remains a need for medical packaging whereby the product is covered and protected in a sterile environment until immediately prior to use. Moreover, there remains a need for a package that stores a booklet, such as an instruction manual, that retains the booklet within the package, that physically separates the booklet from a medical device stored in the package, and that enables medical personnel to easily remove the booklet from the package for use during a surgical procedure.